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Clinical study of the Clin-ToF-I-time of flight mass spectrometry system for detection of Lactobacillus, Streptococcus mutans and Candida albicans

Clinical study of the Clin-ToF-I-time of flight mass spectrometry system for detection of Lactobacillus, Streptococcus mutans and Candida albicans

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-DDT-13003991
Enrollment
Unknown
Registered
2013-12-08
Start date
2013-03-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries, Oral Candidiasis

Interventions

Gold Standard:
Index test:

Sponsors

Peking University School of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria for dental caries were: 1. aged 18-75 years; 2. at least one teeth was diagnosed?of dental caries by clinical manifestation; 3. voluntarily participating and Informed Consent Form being signed. The inclusion criteria for oral Candidiasis were: 1. age range of 18-75 years; 2. diagnosis of oral candidiasis was established based on clinical manifestation and laboratory testing (smear test and fungi culture); 3. patients with positive smear test are eligible for instant enrollment; 4. positive rate of fungi culture>80%; 5. voluntarily participating and Informed Consent Form being signed.

Exclusion criteria

Exclusion criteria: 1. use of systemic or topical antifungal therapy within 2 weeks before study entry; history of systemic disease;hyposalivation; 2. the samples were not isolated none of the three kinds of microorganism; 3. history of pregnancy or breast-feeding; 4. history of psychological disorder that enable to cooperate; 5. history of participating other clinical trials within 4 weeks before study entry; 6. The exclusion criteria for dental caries: diagnosis of severe periodontitis or oral mucosa disease; 7. The exclusion criteria for oral Candidiasis: diagnosis of other systemic fungal infections.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;Consistency;Positive / negative predictive value;Positive / negative likelihood ratio;

Countries

China

Contacts

Public ContactHong Hua

Peking University School of Stomatology

honghua1968@yahoo.com.cn+86 10 82195349

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026